Cannabis is a genus of the flowering plant Cannabis which has long been used for industrial purposes, medicinal purposes, and as a recreational drug. In fact, cannabis-derived products have long been consumed in various forms for centuries. Cannabis is most commonly administered via inhalation or consumption of marijuana-infused food and drink. In particular, the Cannabis plant material has been reported to contain various desirable compounds useful in various pharmaceutical dosage forms and methods for medicinal and industrial purposes as well as uses a recreational drug. Cannabinoids, terpenoids, and flavonoids are included amongst the various suitable and desirable compounds. Cannabis has been reported to provide substantial benefits to patients suffering from a wide range of symptoms experienced in connection with various medical conditions. For example, Cannabis has been reported as being useful to alleviate symptoms associated with anxiety, post-traumatic stress disorder, chronic pain, opiate dependency, paralysis, neuropathy, inflammatory bowel disorders, glaucoma, seizures, epilepsy, autism, cancer, anorexia, spasticity, arthritis, migraine and many other illnesses. As a result, recent research into the use of cannabis-derived products for the treatment of a variety of diseases and conditions has been reaching a feverish pace. In the United States, Cannabis has become an important, emerging medical option in a number of states. It is quickly becoming clear that drug formulations containing specific cannabis-derived chemical compounds can have dramatic affect in improving the lives of many patients.
However, it has been reported that a large number of patients treated with therapeutic treatments involving cannabis-derived pharmaceuticals such as, for example, tetrahydrocannabinol (THC) experience significant tolerance effects. These tolerance effects, for instance, can typically be mitigated to some extent by taking a week or two off from consuming the THC-containing pharmaceutical and then re-commencing use. While this is a relatively minor issue for casual users and recreational users, it can present major problems for medicinal users, especially patients struggling with severe, chronic symptoms associated with conditions like ADHD, autism, and other conditions now known to respond favorably to THC, such as Parkinson's disease. Accordingly, given that Cannabis and various products derived therefrom have become an important medical option for the treatment of a variety of diseases and conditions, there is a growing need for formulations and methods suitable for effectively mitigating one or more tolerance effects developed from ingestion of cannabis-based products.
It has been reported that tolerance effects may be particularly problematic in chronic, pervasive conditions such as Parkinson's disease, Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD). Until the publication of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in 2013, ADHD and ASD were treated as separately-occurring conditions. The DSM-5 continues to list ADHD and ASD as distinct conditions, but for the first time allows for a co-morbid diagnosis of ADHD with ASD because of the apparent frequency of their co-occurrence. Both disorders are believed to share common genetic influences and are associated with similar cognitive, motor and behavioral deficits that can result in academic, emotional, and adaptive problems in school, at home, and elsewhere.
Medscape (www.medscape.com), a resource widely used by physicians and nurses, states that no pharmacologic agent is considered to be effective in the treatment of the core behavioral manifestations of ASD. Second generation antipsychotics have been approved by the FDA for irritability associated with ASD. Selective serotonin reuptake inhibitors (SSRI) are sometimes prescribed to address the intractable repetitive behaviors seen in some patients suffering from ASD. Also, stimulants are considered an effective treatment for symptoms of hyperactivity. However, the long-term safety and efficacy of these three types of commonly-prescribed drugs has not been established.
According to Medscape, atomoxetine, atypical antidepressants, tricyclic antidepressants, and central acting alpha2 agonists are some of the currently-approved treatments for ADHD. Stimulants, such as methylphenidate, dexmethylphenidate, dextroamphetamine and amphetamine mixtures, dextroamphetamine, lisdexamfetamine, and amphetamine are also considered effective treatments for ADHD, but many stimulants have severe drug interactions and serious adverse side effects.
Thus, there is a need for safer and more effective treatments for ASD and ADHD. An ideal treatment would address many of the cognitive, motor, and behavioral symptoms (or deficits) associated with each condition, along with addressing commonly-occurring comorbid conditions.
In one aspect, the present disclosure relates to methods of using tetrahydrocannabinol (THC) to treat patients diagnosed with ADHD and/or ASD and certain commonly-occurring comorbid conditions.